Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089399
Company: SUN PHARM INDS INC
Company: SUN PHARM INDS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | AB | No | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | AB | No | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/14/1987 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/24/2025 | SUPPL-52 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/19/2019 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2016 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/21/2007 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 06/29/2007 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 04/12/2007 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 04/12/2007 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/26/2005 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 05/05/2005 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 09/30/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/2001 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/07/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/2001 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/05/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/22/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 05/15/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/27/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
AMITRIPTYLINE HYDROCHLORIDE
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 202446 | ACCORD HLTHCARE |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 212654 | AIPING PHARM INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 086009 | AUROBINDO PHARMA USA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 213999 | MANKIND PHARMA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 217411 | RISING |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 215376 | RUBICON RESEARCH |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 085968 | SANDOZ |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 089399 | SUN PHARM INDS INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 214548 | UNICHEM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 218389 | UNIQUE PHARM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 210086 | ZYDUS PHARMS |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 202446 | ACCORD HLTHCARE |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 212654 | AIPING PHARM INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 086009 | AUROBINDO PHARMA USA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 213999 | MANKIND PHARMA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 217411 | RISING |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 215376 | RUBICON RESEARCH |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 085968 | SANDOZ |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 089399 | SUN PHARM INDS INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 214548 | UNICHEM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 218389 | UNIQUE PHARM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 210086 | ZYDUS PHARMS |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 202446 | ACCORD HLTHCARE |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 212654 | AIPING PHARM INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 086009 | AUROBINDO PHARMA USA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 213999 | MANKIND PHARMA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 089400 | MUTUAL PHARM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 217411 | RISING |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 215376 | RUBICON RESEARCH |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 085968 | SANDOZ |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 089399 | SUN PHARM INDS INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 214548 | UNICHEM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 218389 | UNIQUE PHARM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 210086 | ZYDUS PHARMS |
TABLET;ORAL; 75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 202446 | ACCORD HLTHCARE |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 212654 | AIPING PHARM INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 086009 | AUROBINDO PHARMA USA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 213999 | MANKIND PHARMA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 217411 | RISING |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 215376 | RUBICON RESEARCH |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | Yes | AB | 085968 | SANDOZ |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 089399 | SUN PHARM INDS INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 214548 | UNICHEM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 218389 | UNIQUE PHARM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 210086 | ZYDUS PHARMS |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 202446 | ACCORD HLTHCARE |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 212654 | AIPING PHARM INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 086009 | AUROBINDO PHARMA USA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 213999 | MANKIND PHARMA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 089402 | MUTUAL PHARM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 217411 | RISING |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 215376 | RUBICON RESEARCH |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 085968 | SANDOZ |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 089399 | SUN PHARM INDS INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 214548 | UNICHEM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 218389 | UNIQUE PHARM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 210086 | ZYDUS PHARMS |
TABLET;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 202446 | ACCORD HLTHCARE |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 212654 | AIPING PHARM INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 086009 | AUROBINDO PHARMA USA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 213999 | MANKIND PHARMA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 217411 | RISING |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 215376 | RUBICON RESEARCH |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | Yes | AB | 085968 | SANDOZ |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 085970 | SANDOZ |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 089399 | SUN PHARM INDS INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 214548 | UNICHEM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 218389 | UNIQUE PHARM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 210086 | ZYDUS PHARMS |